Freedom to Innovate: The Paradox of Patentability in Pharmaceuticals Today

Quest Diagnostics. EverlyWell. Abbott Laboratories. As a few of the many diagnostic companies that are pioneers of medical innovation in the modern age, these pharmaceutical businesses are rolling out new, precise drug therapies at an unprecedented rate to combat specific medical issues by introducing diagnostic methods based on new technologies. The current age of biotechnology continues to challenge lawmakers as innovation unfolds faster than the current existing protective legislature. But no legal issue is more prominent in the biotechnological industry than ownership rights to these new developments.

Recently, one diagnostics case has provided an answer to this question: no one. In February 2019, after months of debate, the United States Court of Appeals for the Federal Circuit reached a decision in the copyright infringement case Athena Diagnostics v. Mayo Collaborative (2019), which concerned Mayo Collaborative’s specific antibody-based method of diagnosis [1]. Athena Diagnostics sued Mayo Collaborative, claiming that they had already patented that particular method of identifying neurological disorders through antibody detection of the protein MuSK under the ‘820 patent [2].

The court decided the case in favor of Mayo Collaborative, rejecting Athena Diagnostics’ claims under two arguments that cited U.S.C 35 Section §101 as a precedent: the discovery of this method of diagnosis was simply an application of “natural law,” and the specific steps taken in the diagnostic process that Athena discovered is not patentable under that natural law [3]. Discoveries attributed to “natural law,” in the context of patentability in medicine, are defined as medical correlations that can be naturally drawn without external or man-made interference. In other words, this diagnostic method specifically could not be categorized as “inventive” and “created by Athena Diagnostics” because it was dictated by the natural biological order of things. Therefore, Athena Diagnostics could not claim the specifics of the process as its own [4].

This decision brings up the issue, which the presiding judge, Pauline Newman, raised in her dissenting opinion: what can be categorized as a diagnostic patent under current court decisions [5]? Other cases involving similar questions of the patentability of medical processes have created a wide range of what is acceptable under the law. Earlier this year, a very similar case was also decided in the Federal Circuit: Endo Pharmaceuticals v. Teva Pharmaceuticals USA (2019) [6]. This case, which focused on a treatment method that used oxymorphone to treat damaged kidneys, referred back to the same case that Athena Diagnostics v. Mayo Collaborative (2019) used as a precedent: Vanda Pharmaceuticals v. West-Ward Pharmaceuticals (2018) [7].

While the more recent two patent infringement cases were decided in favor of the defendants, Vanda Pharmaceuticals v. West-Ward Pharmaceuticals actually was decided in favor of the plaintiff, Vanda Pharmaceuticals [8]. In the decision, the presiding judge ruled in favor of the firm filing the copyright infringement claim, arguing that the patent for iloperidone, an anti-psychotic drug used to treat schizophrenia, is so specific in terms of dosages, process, and testing outcomes that it can be patented as “specific” to the company as a very specific “manmade manipulation” of natural law [9]. However, Vanda Pharmaceuticals’ case was based on comparisons drawn to the precedent case Mayo Collaborative v. Prometheus Laboratories (2012), a case based on a patent that was legally identically, but was conversely decided in favor of the defendant; the differences between both cases were based on a claimed distinction between patenting diagnostic methods versus methods of treatment, but intellectual property academics found the distinction to be weak and untenable [10]. This once again introduced a new aspect of factors to consider in medical patentability, creating an unsteady narrative of rules to follow.

This current pattern of inconsistent precedents attempts to draw a line between what is biologically natural and what is not, but it ultimately fails to create a distinction that can be easily discerned by pharmaceutical companies. By not establishing proper and clear rules for diagnostic patents in biotechnology, current legislation is setting back companies seeking to develop new diagnostic methods. If discoveries in the biotechnical industry cannot clearly be claimed as an original creation, pharmaceutical companies are not incentivized to develop new procedures due to lack of patentability.

In order to set clearer precedent moving forward, the exact distinction between what is categorized as discovery of a natural law versus a man-made invention must be established. Considering the implications of the increasingly murky world of pharmaceutical legislation and the ongoing development in the field of intellectual property law as the use of technology in medicine increases, clear examples need to be established to guide medical-legal decision-making in the future.

Sources:

[1]: "Athena Diagnostics, Inc. v. Mayo Collaborative Services." JD Supra. Accessed May 01, 2019. https://www.jdsupra.com/legalnews/athena-diagnostics-inc-v-mayo-88600/.

[2]:"Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (Fed. Cir. 2019)." Patent Docs. Accessed May 01, 2019. https://www.patentdocs.org/2019/02/athena-diagnostics-inc-v-mayo-collaborative-services-llc-fed-cir-2019.html.

[3]: Ibid.

[4]: "What Happens to Diagnostic Method Patents After Athena?" IPWatchdog.com | Patents & Patent Law. March 07, 2019. Accessed May 01, 2019. https://www.ipwatchdog.com/2019/03/06/diagnostic-method-patents-athena/id=107058/.

[5]: LaSusa, Mike. "Athena Asks Fed. Circ. To Rethink 'Evisceration' Of Patent Law." Law360. Accessed May 01, 2019. https://www.law360.com/articles/1147769/athena-asks-fed-circ-to-rethink-evisceration-of-patent-law.

[6]: "Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2019)." JD Supra. Accessed May 01, 2019. https://www.jdsupra.com/legalnews/endo-pharmaceuticals-inc-v-teva-43058/.

[7]: "Vanda v. West-Ward: This Time, Dosage Adjustment Claims Are Patent Eligible Subject Matter." IPWatchdog.com | Patents & Patent Law. July 10, 2018. Accessed May 01, 2019. https://www.ipwatchdog.com/2018/05/16/vanda-v-west-ward-dosage-adjustment-claims-patent-eligible/id=97117/.

[8]: Ibid.

[9]: Ibid.

[10]: "Mayo Collaborative Services v. Prometheus Laboratories, Inc." Oyez. Accessed May 01, 2019. https://www.oyez.org/cases/2011/10-1150.